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Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV

NCT04249037 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-30

No results posted yet for this study

Summary

This study plans to learn about whether starting HIV treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis.

Conditions

Interventions

DRUG

bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)

A 30 day supply of Bictegravir 50mg/Emtricitabine 200mg/Tenofovir Alafenamide 25mg will be provided to the rapid start arm.

DRUG

Standard initiation of antiretroviral therapy (ART)

Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Hillary Dunlevy, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2023-07-01
Completion
2023-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04249037 on ClinicalTrials.gov